Catalog Number

-

Brand Name

CLARITY® LATERAL RETRACTOR SYSTEM

Version/Model Number

38-DILATOR-22

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 16, 2016

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAD

Product Code Name

RETRACTOR

Public Device Record Key

e6934999-ed6d-4079-b0c0-b3ef354f93bf

Public Version Date

October 14, 2021

Public Version Number

4

DI Record Publish Date

June 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-